MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.053S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Pain (1994); Burning Sensation (2146); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Implanted on an unknown date in 2010.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes employee.(510k): device is not distributed in the united states, but is similar to device marketed in the usa.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: the patient had the initial surgery on an unknown date in 2010; the patient originally underwent an implantation of proximal femoral nail antirotation (pfna-ii) blade titanium alloy (tan), pfna-ii small length nail and pfna-ii end cap extension.The patient was discharged on (b)(6) 2010 to a local residence with home health care.The patient was allowed to travel by air with the surgeon¿s permission on (b)(6) 2011 (it appears that the patient had the initial surgery at another city and was returning to her residence).It was noted that the patient "was" felt a sensation of itching and burning all along the area of surgical operation of the hip joint and the patient had discomfort/pain.Doctors were not able to identify the cause of the burning and itching or pain.The long undiagnosed treatment gave birth to more complications in the body.The reporter alleged that the cause of the itching and burning sensation and pain/ discomfort was a defective metallic implant (j&j).The patient was seen by multiple specialists and multiple unsuccessful efforts were attempted to soothe and calm the patient.There is no documentation available at what treatments were provided or medical assessments by the specialist.Suffering in pain, the patient died in hospital on (b)(6) 2012.This report is for one (1) pfna-ii blade l90 tan.This is report 1 of 3 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device history lot pfna-ii- l90 tan part: 04.027.053s lot: 2651841 manufacturing site: bettlach release to warehouse date: 06.Oct.2010 expiry date: 01.Sep.2020 the device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Complained issue could not be replicated and/or confirmed based on the available information.No pictures and/or x-ray¿s were provided and no material was returned for investigation.Statement from "medical safety officer"; none of these three complaints could possibly result in a death.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFNA-II BLADE L90 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8065270
• MDR Text Key: 126974473
• Report Number: 8030965-2018-58148
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394223
• UDI-Public: (01)07611819394223
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: 04.027.053S
• Device Lot Number: 2651841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention